A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy

Brief Summary

This study will examine the safety and efficacy of the addition of MK-3102 in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

Participants continue basal medication at their pre-study dosage (dosage may be up-titrated during the study only if needed for rescue therapy). Basal medication includes any of the following: sulfonylureas (gliclazide, glibenclamide or glimepiride), glinides (nateglinide, mitiglinide or repaglinide), biguanides (metformin), thiazolidinediones (TZDs) (pioglitazone), alpha-glucosidase inhibitors (acarbose, voglibose or miglitol).

MK-3102 25 mg administered orally once weekly for 52 weeks (24 weeks during Period A and 28 weeks during Period B). Participants continued pre-study basal medication throughout the duration of the study.

Interventions:

Drug: MK-3102

Drug: Basal medication

Placebo Comparator: Placebo

Matching placebo to MK-3102 administered orally once weekly for 24 weeks (Period A) followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Period B). Participants continued pre-study basal medication throughout the duration of the study.

Interventions:

Drug: MK-3102

Drug: Matching placebo to MK-3102

Drug: Basal medication

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

585

Completion Date

May 2014

Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Has type 2 diabetes mellitus

Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy

Exclusion Criteria:

History of type 1 diabetes mellitus or a history of ketoacidosis

History of any of the following medications: TZD (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, MK-3102 anytime

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects